510(k) K262183
K262183 is an FDA 510(k) premarket notification submitted by Shenzhen Nuon Medical Equipment Co., Ltd. for the device "Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)". The FDA issued a decision of Substantially Equivalent on Sep 24, 2026. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Shenzhen Nuon Medical Equipment Co., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 24, 2026
- Date Received
- Jun 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Laser, Comb, Hair
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
- 510(k)
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